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The Conditions and Procedure for the Issue Of Issuer: Minister of Social Affairs Type: regulation In force from: 03.12.2018 In force until: 08.01.2021 Translation published: 29.08.2019 The conditions and procedure for the issue of prescriptions for medicinal products and for the dispensation of medicinal products by pharmacies and the format of the prescription1 Passed 18.02.2005 No. 30 RTL 2005, 23, 315 Entry into force 01.03.2005 Amended by the following acts Passed Published Entry into force 10.04.2006 RTL 2006, 33, 598 23.04.2006 13.12.2007 RTL 2007, 96, 1616 21.12.2007 09.07.2008 RTL 2008, 61, 875 26.07.2008 , partially 1.01.2009 18.09.2008 RTL 2008, 78, 1099 26.09.2008 24.08.2009 RTL 2009, 68, 1011 01.09.2009 08.12.2009 RTL 2009, 93, 1351 01.01.2010 26.02.2010 RTL 2010, 10, 180 08.03.2010 , partially 1.04.2010 24.03.2010 RTL 2010, 15, 289 01.04.2010 12.05.2010 RTL 2010, 26, 457 31.05.2010 15.12.2010 RT I, 23.12.2010, 6 01.01.2011 26.04.2012 RT I, 03.05.2012, 2 01.10.2012 04.02.2013 RT I, 07.02.2013, 2 10.02.2013 06.05.2013 RT I, 10.05.2013, 1 13.05.2013 14.02.2014 RT I, 21.02.2014, 1 01.03.2014 18.03.2014 RT I, 22.03.2014, 1 25.03.2014, partially 01.01.2015 30.06.2014 RT I, 04.07.2014, 14 01.08.2014 10.07.2014 RT I, 12.07.2014, 167 15.07.2014 05.12.2014 RT I, 11.12.2014, 10 14.12.2014 09.09.2015 RT I, 15.09.2015, 3 18.09.2015 23.12.2015 RT I, 05.01.2016, 4 08.01.2016, partially 01.03.2016; 01.07.2016 03.06.2016 RT I, 07.06.2016, 3 10.06.2016 28.12.2016 RT I, 30.12.2016, 4 02.01.2017 22.02.2017 RT I, 07.03.2017, 20 10.03.2017, partially 03.05.2017 13.12.2017 RT I, 21.12.2017, 11 24.12.2017, partially 01.01.2018 15.11.2018 RT I, 20.11.2018, 4 23.11.2018 22.11.2018 RT I, 30.11.2018, 8 01.01.2019 This Regulation is enacted in accordance with subsection 33 (7) of the Medicinal Products Act. § 1. General provisions (1) This regulation establishes: 1) the conditions and procedure for the issue of prescriptions for medicinal products and for the dispensation of medicinal products in accordance with prescriptions or order forms, including requirements for the preservation and registration of medical prescription forms, order forms and cover documents; The conditions and procedure for the issue of prescriptions for medicinal pro... Page 1 / 15 2) the format of prescriptions; 3) the conditions and procedure for the dispensation of medicinal products in accordance with prescriptions issued in the member states of the European Union, member states of the European Economic Area and the Swiss Confederation (hereinafter, ‘EU prescription’); [RTL 2010, 10, 180 – entry into force 08.03.2010] 4) the conditions and procedure for the distance sale of medicinal products. [RT I, 10.05.2013, 1 – entry into force 13.05.2013] (2) The provisions of this regulation apply to the formalisation of prescriptions in relation to the prescribing of veterinary medicinal products by veterinarians in so far as this is not governed by the regulation of the Minister of Rural Affairs enacted in accordance with section 15(7) of the Medicinal Products Act, taking into account the special rules governing the prescribing of veterinary medicinal products, and to the dispensation of medicinal products by pharmacies under veterinary prescriptions. The format of veterinary prescriptions is established by the above-mentioned regulation of the Minister of Rural Affairs. [RT I, 15.09.2015, 3 – entry into force 18.09.2015] (3) No more than one medicinal product may be prescribed in any prescription and no more than one medicinal product may be dispensed under any prescription, except in the case of EU prescriptions. [RTL 2010, 10, 180 – entry into force 08.03.2010] § 2. Issue of prescriptions for medicinal products (1) Prescriptions and order forms may be issued in respect of medicinal products that have a valid marketing authorisation in Estonia, for the preparation of medicinal products as magistral formulae in pharmacies and, in the cases described in subsections 1 and 7 of section 21 of the Medicinal Products Act, for unauthorised medicinal products. If a person qualified to prescribe medicinal products prescribes an unauthorised medicinal product under section 21(1) of the Medicinal Products Act, he/she must submit an application for the use of the unauthorised medicinal product to the State Agency of Medicines. [RT I, 03.05.2012, 2 – entry into force 01.10.2012] (2) Medicinal products may be prescribed for medical purposes and for the purposes of treatment of other persons only by the physicians, dentists, midwives and nurses working with a family physician acting on the basis of a practice list of a family physician, who are authorised to provide health services in the Republic of Estonia in relation to the out-patient treatment of the persons treated by them. [RT I, 05.01.2016, 4 – entry into force 01.03.2016] (21) Prescriptions for medicinal products are issued in electronic form (hereinafter, ‘electronic prescription’) or on paper (hereinafter, ‘paper prescription’). [RT I, 20.11.2018, 4 – entry into force 23.11.2018] (3) Dentists, stating their position title on the prescription, are authorised to prescribe only the following medicinal products and substances: 1) ATC code A01 – stomatological preparations; 2) ATC code B02 – antihemorrhagics; 3) ATC code D06 – antibiotics and chemotherapeutics for dermatological use; 4) ATC code J01 – antibacterials for systemic use; 5) ATC code J02 – antimycotics for systemic use; 6) ATC code J05 – antivirals for systemic use; 7) ATC code H02 – corticosteroids for systemic use; 8) ATC code M01A – anti-inflammatory and antirheumatic products, non-steroids; 9) ATC code M02A – topical products for joint and muscular pain; 10) ATC code N02AX – other opioids and other analgesics and antipyretics, except for prescription narcotic medicinal products; 11) ATC code N05C – hypnotics and sedatives, in the smallest commercially available package size for the proposed treatment, but not exceeding 20 tablets; 12) ATC code R05D – cough suppressants; 13) ATC code R01 – nasal preparations; 14) ATC code R06 – antihistamines for systemic use; 15) ethyl alcohol; 16) other medicinal products for which dental, oral and maxillofacial diseases have been approved as a valid indication in Estonia. [RT I, 07.03.2017, 20 – entry into force 10.03.2017] (31) Midwives, stating their position title on the prescription, are authorised to prescribe only the following medicinal products and substances: 1) ATC code A01AB09 – miconazole, oral gel, treatment of oral, pharyngeal and gastrointestinal candidiasis; 2) ATC code A02B – medicinal products blocking the secretion of gastric acid, except for initial prescriptions; 3) ATC code A03A – drugs for functional gastrointestinal disorders; 4) ATC code B02BA01 – phytomenadione, prophylaxis of neonatal haemorrhagic disease; 5) ATC code B03A – antianemic preparations; 6) ATC code C05A – topical use agents for the treatment of haemorrhoids, except for medicinal products containing glucocorticoids; Page 2 / 15 The conditions and procedure for the issue of prescriptions for medicinal pro... 7) ATC code G01A – anti-infectives for topical use; 8) ATC code G02B – contraceptives for topical use; 9) ATC code G03A – hormonal contraceptives; 10) ATC code G03DA02 – medroxyprogesterone in cases in which the prevention of pregnancy is indicated, except for initial prescriptions; 11) ATC code G03HB01 – combination of cyproterone and oestrogen, except for primary prescription; 12) ATC code H01BB – oxytocin and analogues for oral administration after the delivery of the infant; 13) ATC code J01XE – nitrofuran derivatives; 14) ATC code J02AC01 – fluconazole, oral forms; 15) ATC code J06BB01 – anti-D human immunoglobulin, postnatal prophylaxis of Rh (D) immunisation concerning Rh (D) negative women. [RT I, 30.11.2018, 8 – entry into force 01.01.2019] (32) Nurses working with a family physician acting on the basis of a practice list of a family physician, stating their position title on the prescription, are authorised to prescribe only the following medicinal products and substances: 1) ATC code A10 – medicinal products used in diabetes, except for initial prescriptions; 2) ATC code B01AA03 – warfarin (for treatment of atrial fibrillation), except for initial prescription; 3) ATC code C02, C03, C07 (except for sotalol), C08 and C09 – antihypertensive medicinal products, except for initial prescription; 4) ATC code C10 – lipid modifying agents, except for initial prescription; 5) ATC code D06BA01 – silver sulfadiazine; 6) ATC code G02B, G03A and G03DA02 – hormonal contraceptives, except for initial prescription; 7) ATC code H03A – thyroid hormones, except for initial prescription; 8) ATC code J01XE01 – nitrofurantoin (for treatment of acute uncomplicated cystitis); 9) infant formulae and follow-on formulae, except for initial prescription. [ RT I, 05.01.2016, 4 – entry into force 01.03.2016] (33) A nurse working with a family physician acting on the basis of a practice list of a family physician consults with the family physician a minimum of once during the repeat prescription realisation period, to ascertain whether to continue or to change the treatment. The consultation is recorded in a document certifying the provision of health care services to the patient. [ RT I, 05.01.2016, 4 – entry into force 01.03.2016] (4) Medicinal products for dispensation at the discount rate may be prescribed to persons insured by the Estonian Health Insurance Fund by the persons listed in section 41(2) of the Health Insurance Act and to persons who are insured in a member state of the European Union, a member state of the European Economic Area or the Swiss Confederation (hereinafter, ‘person insured in EU’)and who provide proof of their insurance cover by presenting a valid European health insurance card or the provisional replacement certificate of such a card or a valid certificate in standard format (E112, E123, S2, DA1) issued by a competent agency of the Member State providing the insurance.
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